Massachusetts General Hospital Diabetes Center, Suite 340, 50 Staniford Street, Boston 02114, MA, USA.
J Hum Nutr Diet. 2010 Aug;23(4):336-43. doi: 10.1111/j.1365-277X.2009.01037.x. Epub 2010 Feb 15.
The demand for clinical trials targeting lifestyle intervention has increased as a result of the escalation in obesity, diabetes mellitus and cardiovascular disease. Little is published about the strategies that dietitians have used to successfully screen potential study volunteers, implement interventions and maximise adherence and retention in large multicentre National Institutes of Health funded nutrition and lifestyle intervention clinical trials. This paper discusses an expanded role for the contributions of dietitians as members of an interdisciplinary team based on research experiences in the Diabetes Control and Complications Trial, Diabetes Prevention Program and Look AHEAD (Action for Health in Diabetes). Many of the strategies and insights discussed are also relevant to effective clinical practice. Dietitians need to broaden their scope of practice so that they are integrated proactively into the screening and intervention phases of large clinical trials to maximise retention and adherence to assigned nutrition, lifestyle and behavioural interventions. The skills of dietitians are a unique fit for this work and it is important that investigators and project managers consider including them in both the screening and intervention phases of such clinical trials to maximise retention results.
由于肥胖症、糖尿病和心血管疾病的不断增加,针对生活方式干预的临床试验的需求有所增加。关于营养师成功筛选潜在研究志愿者、实施干预措施以及最大限度地提高大型多中心美国国立卫生研究院资助的营养和生活方式干预临床试验的依从性和保留率所使用的策略,发表的内容很少。本文基于在糖尿病控制和并发症试验、糖尿病预防计划和 LOOK AHEAD(糖尿病中的健康行动)中的研究经验,讨论了营养师作为跨学科团队成员的扩展作用。讨论的许多策略和见解对于有效的临床实践也是相关的。营养师需要扩大其实践范围,以便积极地将其纳入大型临床试验的筛选和干预阶段,以最大限度地提高对指定营养、生活方式和行为干预的依从性。营养师的技能非常适合这项工作,调查人员和项目经理考虑在这些临床试验的筛选和干预阶段将他们纳入其中,以最大限度地提高保留结果非常重要。